PVC材料导管类医疗器械DEHP析出的安全评价试验模型研究
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摘要
众所周知,DEHP(邻苯二甲酸二(2-乙基)己酯)对人类有很严重的危害,也因此得到了广泛关注。由于其与PVC的非共价键结合方式,导致DEHP易从PVC医疗器械中析出,继而接触使用者或病患,造成危害。影响DEHP析出的因素很多,为科学评价PVC材料导管类医疗器械DEHP析出的安全性,该文建立了一种试验模型,通过结合临床使用情况,对影响因素进行了较为全面、系统的分析。以输液器为例,应用本试验模型能对其中DEHP析出的安全性进行评价。
As we all know, DEHP is seriously harmful to human health and consequently has been acquired critical attention. DEHP is able to migrate from PVC medical devices for the non-chemically bound to PVC, thus contact with user and patient. The DEHP migration is influenced by various parameters. In order to assess the security of PVC-tubes medical devices scientifically of DEHP migration, we develop an experimental model by analyzing the parameters comprehensively and systematically, taking into account the clinical practices. For example, assessing the security of DEHP migration from infusion sets by utilizing this model.
As we all know, DEHP is seriously harmful to human health and consequently has been acquired critical attention. DEHP is able to migrate from PVC medical devices for the non-chemically bound to PVC, thus contact with user and patient. The DEHP migration is influenced by various parameters. In order to assess the security of PVC-tubes medical devices scientifically of DEHP migration, we develop an experimental model by analyzing the parameters comprehensively and systematically, taking into account the clinical practices. For example, assessing the security of DEHP migration from infusion sets by utilizing this model.
引文
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[2]谢沁珊,王杉杉,蔡凤云,等.塑料增塑剂DEHP环境污染水平、人体负荷及生物毒性的初步研究[J].公共卫生与预防医学,2010,21(5):19-22.
[3]Bernard L,Cueff R,Chagnon M C,et al.Migration of plasticizers from PVC medical devices:Development of an infusion model[J].Int J Pharm,2015,494(1):136-145.
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[5]Bagel S,Dessaigne B,Bourdeaux D,et al.Influence of lipid type on Bis(2-ethylhexyl)phthalate(DEHP)leaching from infusion line sets in parenteral nutrition[J].J Parenter Enter,2011,35(6):770-775.
[6]Loff S,Kabs F,Subotic U,et al.Kinetics of diethylhexyl-phthalate extraction from polyvinylch-loride-infusion lines[J].J Parenter Enter,2002,26(5):305-309.
[7]Rose R J,Priston M J,Rigby-Jones A E,et al.The effect of temperature on di(2-ethylhexyl)phthalate leaching from PVC infusion sets exposed to lipid emulsions[J].Anaesthesia,2012,67(5):514-520.
[8]Inoue K,Kawaguchi M,Yamanaka R,et al.Evaluation and analysis of exposure levels of di(2-ethylhexyl)phthalate from blood bags[J].Clin Chim Acta,2005,358(1-2):159-166.
[9]Kambia K,Dine T,Gressier B,et al.Evaluation of childhood exposure to di(2-ethylhexyl)phth-alate from perfusion kits during long-term parenteral nutrition[J].Int J Pharm,2003,262(2):83-91.
[10]Dine T,Luyckx M,Cazin M,et al.Rapid determination by high performance liquid chromatogra-phy of Di-2-ethylhexyl phthalate in plasma stored in plastic bags[J].Biomed Chromatogr,1991,5(2):94-97.
[11]Shigeru S,Yoshitada M.Di-2-ethylhexylphthalate(DEHP)content of blood or blood components stored in plastic bags[J].Vox Sang,1978,34(2):81-86.
[2]谢沁珊,王杉杉,蔡凤云,等.塑料增塑剂DEHP环境污染水平、人体负荷及生物毒性的初步研究[J].公共卫生与预防医学,2010,21(5):19-22.
[3]Bernard L,Cueff R,Chagnon M C,et al.Migration of plasticizers from PVC medical devices:Development of an infusion model[J].Int J Pharm,2015,494(1):136-145.
[4]Hanawa T,Muramatsu E,Asakawa K,et al.Investigation of the release behavior of diethylhexyl phthalate from the polyvinylchloride tubing for intravenous administration[J].Int J Pharm,2000,210(1-2):109-115.
[5]Bagel S,Dessaigne B,Bourdeaux D,et al.Influence of lipid type on Bis(2-ethylhexyl)phthalate(DEHP)leaching from infusion line sets in parenteral nutrition[J].J Parenter Enter,2011,35(6):770-775.
[6]Loff S,Kabs F,Subotic U,et al.Kinetics of diethylhexyl-phthalate extraction from polyvinylch-loride-infusion lines[J].J Parenter Enter,2002,26(5):305-309.
[7]Rose R J,Priston M J,Rigby-Jones A E,et al.The effect of temperature on di(2-ethylhexyl)phthalate leaching from PVC infusion sets exposed to lipid emulsions[J].Anaesthesia,2012,67(5):514-520.
[8]Inoue K,Kawaguchi M,Yamanaka R,et al.Evaluation and analysis of exposure levels of di(2-ethylhexyl)phthalate from blood bags[J].Clin Chim Acta,2005,358(1-2):159-166.
[9]Kambia K,Dine T,Gressier B,et al.Evaluation of childhood exposure to di(2-ethylhexyl)phth-alate from perfusion kits during long-term parenteral nutrition[J].Int J Pharm,2003,262(2):83-91.
[10]Dine T,Luyckx M,Cazin M,et al.Rapid determination by high performance liquid chromatogra-phy of Di-2-ethylhexyl phthalate in plasma stored in plastic bags[J].Biomed Chromatogr,1991,5(2):94-97.
[11]Shigeru S,Yoshitada M.Di-2-ethylhexylphthalate(DEHP)content of blood or blood components stored in plastic bags[J].Vox Sang,1978,34(2):81-86.